Dieckmann - Dieckmann Intraosseous Infusion Needle 45 Degree - COOK INCORPORATED

Duns Number:042823948

Device Description: Dieckmann Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 mont Dieckmann Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months)

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More Product Details

Catalog Number

C-DIN-14-3.0-T45-DKM

Brand Name

Dieckmann

Version/Model Number

G05312

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

ac14cbf2-8379-4fd3-9092-d3d71729f82e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10827002053127

Quantity per Package

5

Contains DI Package

00827002053120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COOK INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 669
2 A medical device with a moderate to high risk that requires special controls. 8328
3 A medical device with high risk that requires premarket approval 370
U Unclassified 242